Evidence map›Paper›PMID 37414215›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2023

Long-term outcomes to neoadjuvant pembrolizumab based on pathological response for patients with resectable stage III/IV cutaneous melanoma.

C E Sharon, G N Tortorello, K L Ma, A C Huang, X Xu, L R Giles, S McGettigan, K Kreider, L M Schuchter, A J Mathew and 5 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02434354 (A Phase Ib Tissue Collection Study of Pembrolizumab), which is not on this map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
7.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02434354 phase1completednot on this map

A Phase Ib Tissue Collection Study of Pembrolizumab (MK-3475) in Subjects With Resectable Advanced Melanoma

TypeinterventionalSponsorAbramson Cancer Center at Penn MedicineRan2015 to 2021Enrolled33ConditionsMalignant MelanomaArmspembrolizumab
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 33 citations in OpenAlex.

  1. Updated pan-tumor guidelines for neoadjuvant scoring of pathologic response: a joint SITC and INMC effort.Annals of oncology : official journal of the European Society for Medical Oncology · 2026
    Guideline
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Article
  7. Review
  8. Article
  9. CD8Signal transduction and targeted therapy · 2025
    Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Immunotherapy in Melanoma.Cancer treatment and research · 2025
    Review
  15. Braf-Mutant Melanomas: Biology and Therapy.Current oncology (Toronto, Ont.) · 2024
    Review
  16. Review
  17. Article
  18. Facts and Hopes in Neoadjuvant Immunotherapy: Current Approvals and Emerging Evidence.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Article
  19. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 2 institutions in 1 country.

C E SharonDepartment of Surgery, Hospital of the University of Pennsylvania, Philadelphia.
G N TortorelloDepartment of Surgery, Hospital of the University of Pennsylvania, Philadelphia.
K L MaDepartment of Surgery, Hospital of the University of Pennsylvania, Philadelphia.
A C HuangDepartment of Medicine and Institute for Immunology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
X XuDepartments of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania, Philadelphia.
L R GilesMedicine, Hospital of the University of Pennsylvania, Philadelphia; Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
S McGettiganMedicine, Hospital of the University of Pennsylvania, Philadelphia; Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
K KreiderMedicine, Hospital of the University of Pennsylvania, Philadelphia; Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
L M SchuchterMedicine, Hospital of the University of Pennsylvania, Philadelphia; Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
A J MathewAbramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
R K AmaravadiMedicine, Hospital of the University of Pennsylvania, Philadelphia; Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
P A GimottyDepartment of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA.
J T MiuraDepartment of Surgery, Hospital of the University of Pennsylvania, Philadelphia; Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
G C KarakousisDepartment of Surgery, Hospital of the University of Pennsylvania, Philadelphia; Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
T C MitchellMedicine, Hospital of the University of Pennsylvania, Philadelphia; Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Electronic address: tara.mitchell@pennmedicine.upenn.edu.
Hospital of the University of Pennsylvania · USUniversity of Pennsylvania · US

Funding

UNIVERSITY OF PENNSYLVANIA CAN CTR SUPPORT GRANTP30CA016520 · NCI · UNIVERSITY OF PENNSYLVANIA · PI Robert H. Vonderheide · 1985 to 2026
$222.3M
Targeting exosomal PDL1 to improve immunotherapyP50CA261608 · NCI · WISTAR INSTITUTE · PI HERLYN, MEENHARD F · 2021 to 2025
$11.3M
Role of progenitor exhausted CD8 T cells and the progenitor niche in anti-PD1 efficacyR01CA273018 · NCI · UNIVERSITY OF PENNSYLVANIA · PI HUANG, ALEXANDER · 2022 to 2025
$2.6M
NCI NIH HHS P30 CA016520NCI NIH HHS P50 CA261608NCI NIH HHS R01 CA273018
6 · The paper itself

Abstract

backgroundWhile neoadjuvant immunotherapy for melanoma has shown promising results, the data have been limited by a relatively short follow-up time, with most studies reporting 2-year outcomes. The goal of this study was to determine long-term outcomes for stage III/IV melanoma patients treated with neoadjuvant and adjuvant programmed cell death receptor 1 (PD-1) inhibition. PATIENTS AND

methodsThis is a follow-up study of a previously published phase Ib clinical trial of 30 patients with resectable stage III/IV cutaneous melanoma who received one dose of 200 mg IV neoadjuvant pembrolizumab 3 weeks before surgical resection, followed by 1 year of adjuvant pembrolizumab. The primary outcomes were 5-year overall survival (OS), 5-year recurrence-free survival (RFS), and recurrence patterns.

resultsWe report updated results at 5 years of follow-up with a median follow-up of 61.9 months. No deaths occurred in patients with a major pathological response (MPR, <10% viable tumor) or complete pathological response (pCR, no viable tumor) (n = 8), compared to a 5-year OS of 72.8% for the remainder of the cohort (P = 0.12). Two of eight patients with a pCR or MPR had a recurrence. Of the patients with >10% viable tumor remaining, 8 of 22 patients (36%) had a recurrence. Additionally, the median time to recurrence was 3.9 years for patients with ≤10% viable tumor and 0.6 years for patients with >10% viable tumor (P = 0.044).

conclusionsThe 5-year results from this trial represent the longest follow-up of a single-agent neoadjuvant PD-1 trial to date. Response to neoadjuvant therapy continues to be an important prognosticator with regard to OS and RFS. Additionally, recurrences in patients with pCR occur later and are salvageable, with a 5-year OS of 100%. These results demonstrate the long-term efficacy of single-agent neoadjuvant/adjuvant PD-1 blockade in patients with a pCR and the importance of long-term follow-up for these patients.

trial registrationClinicaltrials.gov, NCT02434354.

Indexed as

Antineoplastic Agents, ImmunologicalMelanomaSkin NeoplasmsAgedAged, 80 and overAntibodies, Monoclonal, HumanizedCutaneous Malignant MelanomaFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoadjuvant TherapyNeoplasm Recurrence, LocalNeoplasm StagingSurvival RateAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalpembrolizumabfollow-up studiesimmunotherapymelanomaneoadjuvant therapyprogrammed cell death 1 receptor

Identifiers

PMID37414215
PMCPMC11232562
OpenAlexW4383102582

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.